Label: PEDESIL MAXIMUM STRENGTH- clotrimazole ointment 

  • NDC Code(s): 24909-301-28
  • Packager: Aidance Skincare & Topical Solutions, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/12

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Clotrimazole 1%

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  • Purpose

    Antifungal

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  • Uses

    • Cures finger and toe area fungal infections.
    • For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort and chafing associated with fungal infection.


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  • Warnings

    For external use only. Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with eyes.

    Keep out of reach of children.

    If swallowed, call poison control or seek medical help.

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  • STOP USE

    Stop and use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.

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  • Directions

    • For nail care, wash and dry affected skin. Apply a thin layer of Pedesil around and under entire nail and cuticle twice daily (morning and night) or as directed by a doctor.
    • If you see improvement within 4 weeks of use, you may continue use until satisfactory results are obtained.
    • For athlete's foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks.
    • If condition persists longer, consult a doctor. Intended for use by normally healthy adults only. Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor. Supervise children in the use of this product.
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  • Other Information


    Store at room temperature.
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  • Other Ingredients

    Beeswax, Bentonite, Eucalyptus Citriodora Oil, Jojoba Seed Oil, Magnesium Oxide, Silver Oxide, Tea Tree Oil,
    Zinc Oxide.

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  • QUESTIONS

    Questions? 877-4-AIDANCE

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  • PRINCIPAL DISPLAY PANEL - 28g Carton
  • INGREDIENTS AND APPEARANCE
    PEDESIL  MAXIMUM STRENGTH
    clotrimazole ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:24909-301
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE 1.0 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    BENTONITE  
    EUCALYPTUS OIL  
    JOJOBA OIL  
    MAGNESIUM OXIDE  
    SILVER OXIDE  
    TEA TREE OIL  
    WHITE WAX  
    ZINC OXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24909-301-28 1 in 1 CARTON
    1 28 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 09/07/2012
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    Name Address ID/FEI Business Operations
    Aidance Skincare & Topical Solutions, LLC 018950611 manufacture(24909-301), label(24909-301)
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